A Shear Force Transfer Coupling for Soft Tissue Repair

描述（由申请人提供）：伤口闭合有时会失败，因为组织缺乏缝合和订书钉所需的有组织的结缔组织。2004年，我们评估了FiberSecure的可行性（第一阶段）；一种与传统闭包根本不同的联轴器：通过剪切而不是直接或法向力来保持。在那项研究和其他研究（骨科和心脏动力应用）中，我们表明，这种成千上万的细聚酯纤维的耦合，以束的形式插入固体组织，迅速向内生长。保持强度达到理论极限，即组织强度本身。这是植物的根原纤维即使在软土中也能牢固地保持的机制。这些试验显示，在高概率（p<0.002在这个阶段I），更强的控制比控制封闭精心应用。有4个具体目标：(1)在资助开始的12个月内验证植入的愈合稳定性，以便识别和解决任何后期变化；(2)通过随机分组研究从组织学，组织化学和强度两种可能有用的变化来选择最终设计；(3)通过与经验丰富的商业合作伙伴的制造过程使设计符合法规（GMP）标准；(4)在GLP（良好实验室规范）认证的设施中研究这些GMP产品180天。测试使用辛克莱微型猪的腹肌模型。实现这4个目标将导致器械在研究方案下用于临床，作为FDA提交的基础。适用510(k)法规。人类和商业利益将是巨大的。虽然传统的耦合在强壮的组织中工作得很好，但许多耦合在组织中经常失效。在许多外科学科中，死亡和残疾随之而来，从缝合的腹部伤口裂开（破裂或裂开），到肌瘤肌切开术或先前剖宫产后围产期子宫破裂，到钝性创伤后各种组织的修复失败，到正常（无疤痕）环空心脏瓣膜置换术中断。每种都可能是致命的。这是一个可以满足这种需求的设备。这项工作是实现这一目标的关键。

DESCRIPTION (provided by applicant): Wound closures sometimes fail because tissues lack the organized connective tissue required by sutures and staples. In 2004, we assessed feasibility (Phase I) of FiberSecure; a coupling fundamentally different from conventional closures: holding is by shear, not direct or normal force. We showed, in that study and others (orthopedic and cardiac power uses), that this coupling of thousands of fine polyester fibers, inserted as bundles are rapidly ingrown by solid tissue. Holding strength reaches theoretical limits i.e., tissue strength itself. It is the mechanism by which root fibrils of plants hold fiercely even in soft soil. These trials have shown, to high probability (p<0.002 in this Phase I), stronger holding than control closures meticulously applied. There are 4 specific aims: (1) Validate healing stability in 12-month implantation begun at funding so any late changes are recognized and addressed (2) Select final design by randomized block study of 2 plausibly useful variations, from histology, histochemistry, and strength, (3) Adapt that design to regulatory (GMP) standards through a manufacturing process with a widely experienced commercial partner, and (4) Study those GMP products for 180 days in a GLP (Good Laboratory Practices) certified facility. Testing uses an abdominal muscle model in Sinclair Miniature Swine. Achieving these 4 aims would result in devices for clinical use under a investigational protocol as the basis for an FDA submission. 510(k) regulations apply. Human and commercial benefit would be enormous. While conventional couplings work quite well for strong tissues, many couplings are in tissues where they too often fail. Mortality and disability follow, across many surgical disciplines, from dehiscence (bursting apart or splitting open) of a sutured abdominal wound, to peripartum uterine rupture after fibroid myotomy or prior cesarean, to unsuccessful repairs of diverse tissues after blunt trauma, to disrupted heart valve replacements in normal (unscarred) annuli. Each may be lethal. This is a device that can address that need. This work is pivotal to its realization.